Events

Rappel de Vivid and LOGIQ Ultrasound Systems

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par GE Healthcare Australia Pty Ltd.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2018-RN-00359-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2018-05-01
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00359-1
  • Notes / Alertes
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Notes supplémentaires dans les données
  • Cause
    Ge healthcare has identified that the system side of the power cord for certain vivid and logiq ultrasound systems may break and expose the electrical conductors leading to the risk of shock. this can lead to injuries up to and including cardiac arrhythmia or cardiac arrest. a minor injury has been reported overseas as a result of this issue.
  • Action
    GE Healthcare will contact users to arrange for a replacement cord to be provided. In the interim, users may continue to use their system until the correction has been implemented only if the system end of the cord is not damaged. Users should ensure all power to the unit is turned off prior to removal of the power cord.

Device

Vivid and LOGIQ Ultrasound Systems
  • Modèle / numéro de série
    Vivid and LOGIQ Ultrasound SystemsLOGIQ 9, LOGIQ E9, Vivid 7, Vivid E7, Vivid E9, Vivid E80, Vivid E90, and Vivid E95 ultrasound systems which have been installed since April 2015 or which have received a power cord replacement since April 2015.ARTG Numbers: 126295, 146317 and 221395
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd